URL Pharma May no Longer be Cash Cow in Philadelphia 3/4/2013 7:44:42 AM

The future looks dicey for the Philadelphia operations of URL Pharma, a decades-old drug company that succeeded in raising the price of a popular gout medicine by 100 times despite an outcry from sufferers of the painful affliction. The price increase was an expected, but unintended, consequence of a Food and Drug Administration program that began in 2006 that tried to lay scientific foundations under medicines in use for decades or centuries, but whose safety and efficacy has not been tested in clinical trials. To get a drug company to pay for such trials, the FDA had to offer something in return, such as market exclusivity. Colchicine, the extract of the autumn crocus plant (also known as meadow saffron), has been used for centuries to deal with the pain of inflamed joints. URL Pharma's subsidiary, Mutual Pharmaceuticals, did enough testing to get approval in 2009 for single-ingredient oral colchicine, which it marketed as Colcrys for the treatment of gout and familial Mediterranean fever. Once the drug was approved, the FDA ordered the nonapproved versions of colchicine removed from the market. URL Pharma took advantage of its new monopoly, raising the price from as little as a nickel per pill to $5 per pill. "This was a case of a well-intentioned FDA and a company that took advantage of a regulatory situation to build a business model that was fantastic," said Audrey Kunis, Temple University Hospital doctor, not entirely approvingly. Dr. Kunis is the president of the American College of Rheumatology, which criticized the decision in 2009. URL Pharma's patented version of colchicine attracted the interest of Takeda Pharmaceuticals Ltd., based in Osaka, Japan, which bought URL Pharma for $800 million in June. But Takeda's only interest was Colcrys, which Takeda said accounted for about 72 percent of the nearly $600 million in sales for URL Pharma in 2011. To reinforce that point, Takeda waited only five months before selling all of URL Pharma -- except for Colcrys -- to India's biggest drug company, Sun Pharmaceuticals Ltd., for an undisclosed price.